Many urological procedures are now performed using minimally invasive endoscopic (e.g., cystoscopic or uteroscopic) techniques. These include examination of the urethra, bladder and ureters, therapeutic treatments for benign prostatic hypertrophy, removal or fragmentation of kidney and bladder stones, the placement of urethral or ureteral stents to facilitate the passage of stones, the performance of biopsies and the excision of tumors. While less invasive than open surgery, these techniques involve procedural irritation and trauma to the urinary tract leading to pain, inflammation and smooth muscle spasm. Postoperative lower urinary tract symptoms (LUTS) following urological procedures often include pain, hyperreflexia (unstable bladder contractions), urinary frequency, nocturia and urgency, and in some cases urinary retention requiring prolonged catheterization.
For some surgical procedures, such as transurethral resection of the prostate (TURP), frequent urination and other symptoms resulting from the procedural irritation and inflammation may continue for a prolonged period, gradually resolving during the first six postoperative weeks. For urologic procedures employing a laser, postoperative complications such as inflammation and muscle spasm may continue for several weeks. Patients are frequently prescribed oral anticholinergic medication to inhibit postoperative spasm and reduce the severity of unstable contractions. However, not all patients respond adequately to these drugs, and side effects may lead to discontinuation of these medications.
Urological procedures are often performed with concurrent irrigation of the urinary tract, to remove blood and tissue debris so that a clear endoscopic field of view is maintained. Conventional irrigation solutions include saline, lactated Ringer's, glycine, sorbitol, manitol and sorbitol/manitol. These conventional irrigation solutions do not contain active pharmaceutical agents.
U.S. Pat. No. 5,858,017 to Demopulos, et al., the disclosure of which is hereby incorporated by reference, discloses surgical irrigation solutions and methods for the inhibition of pain, inflammation and/or spasm. The use of irrigation solutions containing pain/inflammation inhibitors and anti-spasm agents during urological procedures in general and during TURP specifically is disclosed, including five-drug and nine-drug combinations. This reference does not teach optimized pairings of a pain/inflammation inhibitory agent with an anti-spasm agent for given urological procedures.